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VESANOID 10MG SOFT CAPSULES

Active substance(s): TRETINOIN / TRETINOIN

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taken or might take any other medicines. This includes medicines
obtained without a prescription and herbal medicines.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Vesanoid

This is extremely important, as using more than one medicine at
the same time can strengthen or weaken the effect of the medicines.
Therefore, you should not take Vesanoid with any other drug unless
you have told your doctor and they have agreed.

®

10 mg soft capsules
Tretinoin

While you are taking Vesanoid do not take:
• tetracyclines (a type of antibiotic)
• vitamin A
• low-dose progestogens for birth control (mini-pill). If you are
taking low-dose progestogens for birth control, your doctor
will tell you to stop and prescribe a different oral contraceptive.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.

Medicines which may require particular care when taken with
Vesanoid include:
• rifampicin and erythromycin (antibiotics)
• glucocorticoids (for allergies and inflammation)
• phenobarbital (for epilepsy)
• pentobarbital (for insomnia)
• ketoconazole (an antifungal)
• cimetidine (for stomach ulcers)
• verapamil and diltiazem (for heart conditions or high blood
pressure)
• ciclosporin (used following organ or bone marrow transplants)
• tranexamic acid, aminocaproic acid and aprotinin (used to
reduce bleeding).

What is in this leaflet:
1. What Vesanoid is and what it is used for
2. What you need to know before you take Vesanoid
3. How to take Vesanoid
4. Possible side effects
5. How to store Vesanoid
6. Contents of the pack and other information

Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any
medicine.

1. What Vesanoid is and what it is used for
Vesanoid contains a medicine called tretinoin. This belongs to a
group of medicines called ‘retinoids’. These medicines are similar
to vitamin A.

Before starting treatment with Vesanoid
Tell your doctor immediately if:
• you are pregnant,
• you think you are pregnant,
• you intend to become pregnant.
You should not become pregnant during and within one month
(four weeks) after stopping treatment with Vesanoid.
If you do become pregnant while taking Vesanoid, it is very
likely that your baby will be born deformed.

Vesanoid is used to treat a type of blood problem called ‘acute promyelocytic leukaemia’. It works by slowing the growth of certain
types of diseased blood cells.
2. What you need to know before you take Vesanoid

Do not take Vesanoid if you are allergic to:
• tretinoin or any of the other ingredients of this medicine
(listed in section 6)
• other ‘retinoid’ medicines. These include isotretinoin, acitretin
and tazarotene
• peanuts or soya. This is because Vesanoid contains soya-bean oil.

During treatment with Vesanoid
• During treatment with Vesanoid and four weeks after
stopping, you and your partner should practice effective
and continued contraception (birth control).
Your doctor will tell you what methods of contraception you
can use. If you are taking low-dose progestogens (mini-pill)
for birth control, your doctor will tell you to stop and
prescribe a different oral contraceptive for you.
• Women taking Vesanoid should take a pregnancy test every
month during treatment with Vesanoid.
• Tell your doctor immediately if you become pregnant
while taking Vesanoid. You and your doctor will discuss
the right treatment for you if you are pregnant and have
acute promyelocytic leukaemia.

Do not take Vesanoid if:
• you are pregnant, planning to become pregnant or breastfeeding (see section 2, Pregnancy, breast-feeding and fertility)
• you are taking vitamin A, tetracyclines or retinoids.
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Vesanoid.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vesanoid if:
• you have any other illness
• you have allergies
• you have been told by your doctor that you have an intolerance
to some sugars. This is because Vesanoid contains sorbitol.

Do not breast-feed your baby while taking Vesanoid.
Vesanoid enters the breast milk, and could therefore harm your
baby.
Driving and using machines
Your ability to drive or operate machinery might be impaired
while you are taking Vesanoid, especially if you are feeling
dizzy or have a severe headache.

If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Vesanoid.
Look out for important side effects
Vesanoid can cause side effects including:
• a severe headache with feeling or being sick
• difficulty in breathing
• fever
• feeling dizzy
• chest or back pain.
You will need to look out for these while you are taking Vesanoid.
See “Important side effects” in section 4 for more details. Your
doctor may decide to change the dose of your medicine or to
prescribe an additional medicine.

Vesanoid contains soya-bean oil and sorbitol
Vesanoid contains soya-bean oil. If you are allergic to peanut or
soya, do not take this medicine.
Vesanoid contains sorbitol (a type of sugar). If you have been
told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
3. How to take Vesanoid
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

Children
There is limited safety and efficacy information on the use of
tretinoin in children.
Other medicines and Vesanoid
Tell your doctor or pharmacist if you are taking, have recently
1

How much to take
Depending on the nature of your illness, your reaction to
Vesanoid, your body weight and body height, your doctor will
prescribe a dose that is right for you. Do not change the prescribed
dose yourself. If you feel that the effect of Vesanoid is too strong
or too weak, talk to your doctor or pharmacist.
Please turn over

Adults
The daily dose will be 45 mg/m2 and will be about 8 capsules a
day divided into two equal doses.

of the lips, vomiting, diarrhoea or constipation
• changes to your blood (shown in tests) such as higher levels
of transaminases, blood creatinine or blood fats (triglycerides
and cholesterol).

Children
The daily dose will be 45 mg/m2 divided into two equal doses.
For children who suffer from bad headaches during treatment a
lower daily dose of 25 mg/m² should be considered.

Not known (frequency cannot be estimated from the available data):
• genital ulcers
• serious bacterial infections (necrotising fasciitis)
• kidney problems (renal infarct)
• swollen muscles or swollen blood vessels (vasculitis)
• red painful lumps under the skin, most likely on your legs
(erythema nodosum)
• loss of appetite, feeling or being sick, with a headache, feeling
drowsy or weak (possible sign of too much calcium in your blood)
• other changes to your blood (shown in tests) such as too many
platelets (thrombocytosis), a change in the number of white
blood cells (basophilia) or increased histamine levels.

Adults with kidney or liver diseases
The daily dose will be 25 mg/m2 divided into two equal doses.
You will take Vesanoid for up to a maximum of 90 days. During
therapy with Vesanoid or immediately after, your doctor will start
treatment with other medicines.
Taking this medicine
Swallow the capsules whole with water, preferably with a meal or
shortly thereafter. Do not chew the capsules.
If you take more Vesanoid than you should
If you or another person have taken an overdose of Vesanoid,
you must contact your doctor, pharmacist or the nearest hospital
immediately.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via theYellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety
of this medicine.

If you forget to take Vesanoid
If you forget to take one dose, take your capsules as soon as
you remember and tell your doctor immediately. Do not take a
double dose to make up for a forgotten dose.

5. How to store Vesanoid

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the carton and bottle label after EXP. The expiry date refers to
the last day of that month.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. In addition to the benefits,
nearly everyone will get some undesirable effects during
treatment. This is true, even when Vesanoid is used correctly.

Do not store above 30°C.
Keep the bottle tightly closed in order to protect from moisture.
Keep the bottle in the outer carton in order to protect from light.

Important side effects
Tell your doctor immediately, if you notice any of the following:
• fever, especially with breathing difficulties, coughing, feeling
dizzy, chest pain and abdominal pain
• a severe headache with feeling or being sick, difficulty in
breathing, fever, feeling dizzy, or chest or back pain. Your doctor
may decide to change the dose of your medicine or to prescribe
an additional medicine
• severe stomach pain which spreads to your back (possible sign
of pancreatitis)
• fever with dark lumpy markings on your skin, most likely on
your face and neck (possible sign of “Sweet’s syndrome” or acute
febrile neutrophilic dermatosis)
• a painful swelling in your leg, sudden chest pain or difficulty
breathing (possible sign of a blood clot)
• a pain in your chest that spreads to your arm or neck (possible
sign of a heart attack)
• double vision and feeling dizzy, especially with feeling or
being sick, ringing in your ears and headache (possible sign of
increased pressure in your head)
• an unexplained headache or migraine, which can include
disturbed vision (possible sign of a stroke).
Tell your doctor immediately if you notice any of the side effects
listed above.

Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.

Other side effects
Very common (may affect more than 1 in 10 people):
• hair loss
• an irregular heartbeat
• changes to your eyesight or hearing
• bone or joint pain, chest pain or abdominal pain
• skin rash, itching, redness, peeling or inflammation
• dry skin, mouth or nose; swollen, dry or cracked lips
• breathing difficulties such as asthma, which may get worse
(respiratory failure)
• conjunctivitis or dry eyes, which may be a problem if you
wear contact lenses
• difficulty sleeping
• sweating more than usual
• headache or feeling dizzy
• feeling tired, cold or generally unwell
• feeling confused, worried or depressed
• pins and needles or numbness of your hands or feet
• loss of appetite, feeling or being sick, stomach upset, stomach
ache, inflammation of the pancreas (pancreatitis), inflammation

For information about this medicine, contact the medical
information department on 0800 145 5034 or email:
cheplapharm@redlinepv.co.uk.

6. Contents of the pack and other information
What Vesanoid contains
• The active substance is tretinoin. Each soft capsule contains
10 mg tretinoin.
• The other ingredients in the soft capsule contents are yellow
beeswax, hydrogenated soya-bean oil, partially hydrogenated
soya-bean oil and soya-bean oil (see section 2).
• The other ingredients in the soft capsule shell are gelatin, glycerol
(E 422), karion 83 containing sorbitol (see section 2), mannitol
and starch (maize), and the colorants titanium dioxide (E 171),
iron oxide yellow (E 172) and iron oxide red (E 172).
What Vesanoid looks like and contents of the pack
Vesanoid soft capsules are bi-coloured, orange-yellow and reddishbrown. They are packed in glass bottles containing 100 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a, 17498 Mesekenhagen
Germany

Manufacturer
CENEXI SAS
52, rue M. et J. Gaucher
94120 Fontenay-sous-Bois
France
This medicinal product is authorised in the Member States
of the EEA under the following names:
Tretinoin, Vesanoid
This leaflet was last revised in April 2017

2

GB 9000695/13

taken or might take any other medicines. This includes medicines
obtained without a prescription and herbal medicines.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Vesanoid

This is extremely important, as using more than one medicine at
the same time can strengthen or weaken the effect of the medicines.
Therefore, you should not take Vesanoid with any other drug unless
you have told your doctor and they have agreed.

®

10 mg soft capsules
Tretinoin

While you are taking Vesanoid do not take:
• tetracyclines (a type of antibiotic)
• vitamin A
• low-dose progestogens for birth control (mini-pill). If you are
taking low-dose progestogens for birth control, your doctor
will tell you to stop and prescribe a different oral contraceptive.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.

Medicines which may require particular care when taken with
Vesanoid include:
• rifampicin and erythromycin (antibiotics)
• glucocorticoids (for allergies and inflammation)
• phenobarbital (for epilepsy)
• pentobarbital (for insomnia)
• ketoconazole (an antifungal)
• cimetidine (for stomach ulcers)
• verapamil and diltiazem (for heart conditions or high blood
pressure)
• ciclosporin (used following organ or bone marrow transplants)
• tranexamic acid, aminocaproic acid and aprotinin (used to
reduce bleeding).

What is in this leaflet:
1. What Vesanoid is and what it is used for
2. What you need to know before you take Vesanoid
3. How to take Vesanoid
4. Possible side effects
5. How to store Vesanoid
6. Contents of the pack and other information

Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any
medicine.

1. What Vesanoid is and what it is used for
Vesanoid contains a medicine called tretinoin. This belongs to a
group of medicines called ‘retinoids’. These medicines are similar
to vitamin A.

Before starting treatment with Vesanoid
Tell your doctor immediately if:
• you are pregnant,
• you think you are pregnant,
• you intend to become pregnant.
You should not become pregnant during and within one month
(four weeks) after stopping treatment with Vesanoid.
If you do become pregnant while taking Vesanoid, it is very
likely that your baby will be born deformed.

Vesanoid is used to treat a type of blood problem called ‘acute promyelocytic leukaemia’. It works by slowing the growth of certain
types of diseased blood cells.
2. What you need to know before you take Vesanoid

Do not take Vesanoid if you are allergic to:
• tretinoin or any of the other ingredients of this medicine
(listed in section 6)
• other ‘retinoid’ medicines. These include isotretinoin, acitretin
and tazarotene
• peanuts or soya. This is because Vesanoid contains soya-bean oil.

During treatment with Vesanoid
• During treatment with Vesanoid and four weeks after
stopping, you and your partner should practice effective
and continued contraception (birth control).
Your doctor will tell you what methods of contraception you
can use. If you are taking low-dose progestogens (mini-pill)
for birth control, your doctor will tell you to stop and
prescribe a different oral contraceptive for you.
• Women taking Vesanoid should take a pregnancy test every
month during treatment with Vesanoid.
• Tell your doctor immediately if you become pregnant
while taking Vesanoid. You and your doctor will discuss
the right treatment for you if you are pregnant and have
acute promyelocytic leukaemia.

Do not take Vesanoid if:
• you are pregnant, planning to become pregnant or breastfeeding (see section 2, Pregnancy, breast-feeding and fertility)
• you are taking vitamin A, tetracyclines or retinoids.
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Vesanoid.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vesanoid if:
• you have any other illness
• you have allergies
• you have been told by your doctor that you have an intolerance
to some sugars. This is because Vesanoid contains sorbitol.

Do not breast-feed your baby while taking Vesanoid.
Vesanoid enters the breast milk, and could therefore harm your
baby.
Driving and using machines
Your ability to drive or operate machinery might be impaired
while you are taking Vesanoid, especially if you are feeling
dizzy or have a severe headache.

If any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Vesanoid.
Look out for important side effects
Vesanoid can cause side effects including:
• a severe headache with feeling or being sick
• difficulty in breathing
• fever
• feeling dizzy
• chest or back pain.
You will need to look out for these while you are taking Vesanoid.
See “Important side effects” in section 4 for more details. Your
doctor may decide to change the dose of your medicine or to
prescribe an additional medicine.

Vesanoid contains soya-bean oil and sorbitol
Vesanoid contains soya-bean oil. If you are allergic to peanut or
soya, do not take this medicine.
Vesanoid contains sorbitol (a type of sugar). If you have been
told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
3. How to take Vesanoid
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

Children
There is limited safety and efficacy information on the use of
tretinoin in children.
Other medicines and Vesanoid
Tell your doctor or pharmacist if you are taking, have recently
1

How much to take
Depending on the nature of your illness, your reaction to
Vesanoid, your body weight and body height, your doctor will
prescribe a dose that is right for you. Do not change the prescribed
dose yourself. If you feel that the effect of Vesanoid is too strong
or too weak, talk to your doctor or pharmacist.
Please turn over

Adults
The daily dose will be 45 mg/m2 and will be about 8 capsules a
day divided into two equal doses.

of the lips, vomiting, diarrhoea or constipation
• changes to your blood (shown in tests) such as higher levels
of transaminases, blood creatinine or blood fats (triglycerides
and cholesterol).

Children
The daily dose will be 45 mg/m2 divided into two equal doses.
For children who suffer from bad headaches during treatment a
lower daily dose of 25 mg/m² should be considered.

Not known (frequency cannot be estimated from the available data):
• genital ulcers
• serious bacterial infections (necrotising fasciitis)
• kidney problems (renal infarct)
• swollen muscles or swollen blood vessels (vasculitis)
• red painful lumps under the skin, most likely on your legs
(erythema nodosum)
• loss of appetite, feeling or being sick, with a headache, feeling
drowsy or weak (possible sign of too much calcium in your blood)
• other changes to your blood (shown in tests) such as too many
platelets (thrombocytosis), a change in the number of white
blood cells (basophilia) or increased histamine levels.

Adults with kidney or liver diseases
The daily dose will be 25 mg/m2 divided into two equal doses.
You will take Vesanoid for up to a maximum of 90 days. During
therapy with Vesanoid or immediately after, your doctor will start
treatment with other medicines.
Taking this medicine
Swallow the capsules whole with water, preferably with a meal or
shortly thereafter. Do not chew the capsules.
If you take more Vesanoid than you should
If you or another person have taken an overdose of Vesanoid,
you must contact your doctor, pharmacist or the nearest hospital
immediately.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety
of this medicine.

If you forget to take Vesanoid
If you forget to take one dose, take your capsules as soon as
you remember and tell your doctor immediately. Do not take a
double dose to make up for a forgotten dose.

5. How to store Vesanoid

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the carton and bottle label after EXP. The expiry date refers to
the last day of that month.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. In addition to the benefits,
nearly everyone will get some undesirable effects during
treatment. This is true, even when Vesanoid is used correctly.

Do not store above 30°C.
Keep the bottle tightly closed in order to protect from moisture.
Keep the bottle in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.

Important side effects
Tell your doctor immediately, if you notice any of the following:
• fever, especially with breathing difficulties, coughing, feeling
dizzy, chest pain and abdominal pain
• a severe headache with feeling or being sick, difficulty in
breathing, fever, feeling dizzy, or chest or back pain. Your doctor
may decide to change the dose of your medicine or to prescribe
an additional medicine
• severe stomach pain which spreads to your back (possible sign
of pancreatitis)
• fever with dark lumpy markings on your skin, most likely on
your face and neck (possible sign of “Sweet’s syndrome” or acute
febrile neutrophilic dermatosis)
• a painful swelling in your leg, sudden chest pain or difficulty
breathing (possible sign of a blood clot)
• a pain in your chest that spreads to your arm or neck (possible
sign of a heart attack)
• double vision and feeling dizzy, especially with feeling or
being sick, ringing in your ears and headache (possible sign of
increased pressure in your head)
• an unexplained headache or migraine, which can include
disturbed vision (possible sign of a stroke).
Tell your doctor immediately if you notice any of the side effects
listed above.
Other side effects
Very common (may affect more than 1 in 10 people):
• hair loss
• an irregular heartbeat
• changes to your eyesight or hearing
• bone or joint pain, chest pain or abdominal pain
• skin rash, itching, redness, peeling or inflammation
• dry skin, mouth or nose; swollen, dry or cracked lips
• breathing difficulties such as asthma, which may get worse
(respiratory failure)
• conjunctivitis or dry eyes, which may be a problem if you
wear contact lenses
• difficulty sleeping
• sweating more than usual
• headache or feeling dizzy
• feeling tired, cold or generally unwell
• feeling confused, worried or depressed
• pins and needles or numbness of your hands or feet
• loss of appetite, feeling or being sick, stomach upset, stomach
ache, inflammation of the pancreas (pancreatitis), inflammation

6. Contents of the pack and other information
What Vesanoid contains
• The active substance is tretinoin. Each soft capsule contains
10 mg tretinoin.
• The other ingredients in the soft capsule contents are yellow
beeswax, hydrogenated soya-bean oil, partially hydrogenated
soya-bean oil and soya-bean oil (see section 2).
• The other ingredients in the soft capsule shell are gelatin,
glycerol (E 422), karion 83 containing sorbitol (see section 2),
mannitol and starch (maize), and the colorants titanium dioxide
(E 171), iron oxide yellow (E 172) and iron oxide red (E 172).
What Vesanoid looks like and contents of the pack
Vesanoid soft capsules are bi-coloured, orange-yellow and reddishbrown. They are packed in glass bottles containing 100 capsules.
Marketing Authorisation Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a
17498 Mesekenhagen
Germany
For information about this medicine, contact the medical
information department on 0800 145 5034 or email:
cheplapharm@redlinepv.co.uk.
This medicinal product is authorised in the Member States
of the EEA under the following names:
Tretinoin, Vesanoid
This leaflet was last revised in April 2017

2

GB 9000695/13

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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